Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
docetaxel
Teva B.V.
L01CD02
docetaxel
Antineoplastic agents
Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Breast cancerDocetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Revision: 18
Withdrawn
2010-01-26
103 B. PACKAGE LEAFLET Medicinal product no longer authorised 104 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOCETAXEL TEVA 20 MG/0.72 ML CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION docetaxel READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, hospital pharmacist or nurse. - If you get any side effects talk to your doctor, hospital pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Docetaxel Teva is and what it is used for 2. What you need to know before you use Docetaxel Teva 3. How to use Docetaxel Teva 4. Possible side effects 5. How to store Docetaxel Teva 6. Contents of the pack and other information 1. WHAT DOCETAXEL TEVA IS AND WHAT IT IS USED FOR The name of this medicine is Docetaxel Teva. Docetaxel is a substance derived from the needles of yew trees. Docetaxel belongs to the group of anti-cancer medicines called taxoids. Docetaxel Teva has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, Docetaxel Teva could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. - For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Teva could be administered in combination with doxorubicin and cyclophosphamide. - For the treatment of lung cancer, Docetaxel Teva could be administered either alone or in combination with cisplatin. - For the treatment of prostate cancer, Docetaxel Teva is administered in combination with prednisone or prednisolone. - For the treatment of metastatic gastric cancer, Docetaxel Teva is administered in combination with cisplatin and 5-fluorouracil. - For the treatment o Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg docetaxel. Each ml of concentrate contains 27.73 mg docetaxel. Excipients with known effect: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (181 mg of anhydrous ethanol). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate and solvent for solution for infusion. The concentrate is a clear viscous, yellow to brown-yellow solution. The solvent is a colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: • operable node-positive breast cancer • operable node-negative breast cancer For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1). Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced o Прочетете целия документ